Antibiotic or Not in Non-purulent Exacerbations of COPD: a Trial of Security and Efficacy (AEPOC-ATB)
Utility of Antibiotic Treatment in Acute Non-purulent Exacerbations of COPD: a Double Blinded, Randomized, Placebo-controlled Trial of Security and Efficacy
COPD is one of the most important causes of morbidity and mortality and supposes a sanitary problem in Europe and USA. Patients with COPD usually have 1-2 episodes of acute exacerbation of COPD (AECOPD) per year, being these the principal causes of of hospitalizations, respiratory problems and medical visits. After an episode of AECOPD, the majority of patients develop a transitory (or permanent) worsening in their quality of life and 50% of them will require a new hospitalization. Globally, a 75%& of the exacerbations might be associated with a respiratory tract infection, and among them, 50% might be related to bacteria and in 45% an evidence of viral infection could be documented. Even though the antibiotic treatment might not be useful for a majority of patients with AECOPD, is generalized its use(almost an 85% in some series) in hospitalized patients. The non-controlled use of antibiotics in AECOPD results in a very expensive disease and raises the rate of resistance of bacteria. The available literature have shown that there's a relation between exacerbations and infections, based on sputum samples.
In summary, is well known that at least a 50% of the episodes of AECOPD might be associated with pathogenic bacteria in the lower respiratory tract. Prescription of antibiotics is wide and generalized in hospitalized patients. Clinical trials have shown correlation between AECOPD with sputum purulence (which correlates with presence of bacteria), however they've not included NON-purulent AECOPD, even though they're a significative group of patients hospitalized by this cause too. It's necessary to evaluate the efficacy nor the security of antibiotic treatment in this group of patients in a well designed trial.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Barcelona、スペイン、08006
- Hospital Clínica Platón
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Aragon
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Zaragoza、Aragon、スペイン、50009
- Hospital Miquel Servet
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Catalonia
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Barcelona、Catalonia、スペイン、08036
- Fundacio Clinic Per la Recerca Biomèdica - Hospital Clinic de Barcelona
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Comunitat Valenciana
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Valencia、Comunitat Valenciana、スペイン、46009
- Fundació La Fe- Hospital La Fe
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- COPD diagnosis according to GOLD guidelines
- Hospitalization for any acute exacerbation of chronic obstructive pulmonary disease
- Failure of outpatient treatment
- Increasing of dyspnea in the last days
- Comorbidity that causes detriment of respiratory function
Exclusion Criteria:
- Life expectancy of less than 6 months
- Mechanical Ventilation
- Cardiovascular condition that causes exacerbation
- Immunosuppression
- Pulmonary infiltrates that suggest pneumonia
- Antibiotic treatment in the last month
- Pregnancy
- ECG with a large QT segment
- Hypokalemia
- Hepatic failure or renal failure
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし:Non-Antibiotic
Patients will not receive antibiotics, although the study is double-blind.
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アクティブコンパレータ:Antibiotic
Patients will receive in a masked way, moxifloxacin.
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Moxifloxacin 400 mg administered once a day for 5 days
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
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Efficacy of treatment WITHOUT antibiotics in non-purulent exacerbations of COPD
時間枠:Six months
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Six months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Efficacy/Safety in treatment on re-hospitalizations at six months.
時間枠:Six monts
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Six monts
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In-hospital stay (days)
時間枠:Six months
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Six months
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All cause mortality
時間枠:One and Six months
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One and Six months
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Quality of Life (QoL) measured by the Saint George Respiratory Questionnaire
時間枠:Hospitalization day 1 and six months
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This item will be measured by the application of the Saint George Respiratory Questionnaire (SGRQ)
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Hospitalization day 1 and six months
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協力者と研究者
捜査官
- 主任研究者:Nestor Soler, MD,PhD、Hospital Clinic of Barcelona
出版物と役立つリンク
一般刊行物
- Connors AF Jr, Dawson NV, Thomas C, Harrell FE Jr, Desbiens N, Fulkerson WJ, Kussin P, Bellamy P, Goldman L, Knaus WA. Outcomes following acute exacerbation of severe chronic obstructive lung disease. The SUPPORT investigators (Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments). Am J Respir Crit Care Med. 1996 Oct;154(4 Pt 1):959-67. doi: 10.1164/ajrccm.154.4.8887592. Erratum In: Am J Respir Crit Care Med 1997 Jan;155(1):386.
- Murray CJ, Lopez AD, Black R, Mathers CD, Shibuya K, Ezzati M, Salomon JA, Michaud CM, Walker N, Vos T. Global burden of disease 2005: call for collaborators. Lancet. 2007 Jul 14;370(9582):109-110. doi: 10.1016/S0140-6736(07)61064-2. No abstract available.
- Snow V, Lascher S, Mottur-Pilson C; Joint Expert Panel on COPD of the American College of Chest Physicians and the American College of Physicians-Amercian Society of Internal Medicine. The evidence base for management of acute exacerbations of COPD: clinical practice guideline, part 1. Chest. 2001 Apr;119(4):1185-9. doi: 10.1378/chest.119.4.1185. No abstract available.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- AEPOC-ATB
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